FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
APPLICATOR, LEE IMPRESSION
K Number: K781977
·
Decision Dec 20, 1978
Classifications
1
FEI Numbers
166
Registration Numbers
166
Same Product Code
12
Applicant Total
29
Review Days
23
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- APPLICATOR, LEE IMPRESSION
- K Number
- K781977
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Lee Pharmaceuticals
- Date Received
- November 27, 1978
- Decision Date
- December 20, 1978
- Product Code
- EID
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EID | Syringe, Restorative And Impression Material | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EID), ordered by most recent decision date.
BONE GRAFT DELIVERY SYRINGES
FDA 510(k)
FDA Class 1
·Dental
ACCESS IMPRESSION BARREL
FDA 510(k)
FDA Class 1
·Dental
CAULK'S VPS CARTRIDGE SYSTEM
FDA 510(k)
FDA Class 1
·Dental
IMPRESSION SYRINGE
FDA 510(k)
FDA Class 1
·Dental
COLTENE JET-MIXER
FDA 510(k)
FDA Class 1
·Dental
CENTRIX RIBBON TUBES
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Lee Pharmaceuticals
| K Number | Device Name | ||
|---|---|---|---|
| K924378 | RESTOBOND 4 | Mar 31, 1993 | Substantially Equivalent |
| K912256 | PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT | Jul 24, 1991 | Substantially Equivalent |
| K900809 | LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETS | Jun 28, 1990 | Substantially Equivalent |
| K894315 | RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT | Oct 31, 1989 | Substantially Equivalent |
| K881903 | PROSTHODENT VL | Jul 1, 1988 | Substantially Equivalent |
| K873123 | LEE COMPOSITE INLAY SYSTEM | Jan 20, 1988 | Substantially Equivalent |
| K863157 | RESTODENT POSTERIOR | Sep 25, 1986 | Substantially Equivalent |
| K854882 | PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT | Jan 30, 1986 | Substantially Equivalent |
| K844133 | CLEANSE N BOND I | Jan 4, 1985 | Substantially Equivalent |
| K844134 | CLEANSE N BOND II | Jan 4, 1985 | Substantially Equivalent |